Clinical trials and tribulations

August 3, 2020
It’s August. While things may be slowing down in Washington, the biotech industry is still working as hard as ever. Today we dive into Dr. Michelle McMurry-Heath’s first episode of the I AM BIO Podcast, featuring Moderna’s Chief Medical Officer, as well as what USDA’s…

It’s August. While things may be slowing down in Washington, the biotech industry is still working as hard as ever. Today we dive into Dr. Michelle McMurry-Heath’s first episode of the I AM BIO Podcast, featuring Moderna’s Chief Medical Officer, as well as what USDA’s doing to support agricultural innovation. Here are 650 words, 3 minutes, 15 seconds.

Clinical trials and tribulations

On her first episode of the I AM BIO Podcast, Dr. Michelle McMurry-Heath speaks with Dr. Tal Zaks, Chief Medical Officer of Moderna. He answers questions on everyone’s minds: how the biotech company took a COVID-19 vaccine to trial so quickly, how they select trial participants, and most importantly, whether or not he thinks the vaccine will work.

As we reported last week, BIO member Moderna became the first company to bring a COVID-19 vaccine to a Phase 3 clinical trial, which will test for safety and efficacy in 30,000 people across the United States.

Everyone wants to know—will we ever get a COVID-19 vaccine? Dr. Zaks thinks yes. Moderna has been able to leverage its mRNA technology to develop a vaccine and begin trials much faster. “But it's not just about the speed to start. It's actually also about your ability to then scale up manufacturing and production,” he said.

But, really, how did Moderna move so fast? There are two factors: Moderna’s platform, and the fact that the pandemic allows them to test the efficacy of a vaccine much faster and easier than for diseases that aren’t as widespread. 

How do they select trial participants? They first look for people who are most likely to benefit from the vaccine because of where they work or live, or people who are more likely to get sick from the virus.

And because COVID-19 disproportionately affects communities of color, they’ve also worked to make the trial more racially diverse—by committing to transparency and clearly communicating what they’re doing and why, as well as collaborating with community organizations. 

You’ll want to listen to the whole thing to learn how Moderna’s platform works, how companies choose or exclude patients from trials, how to overcome the legacy of the Tuskegee experiments, and how to use data to persuade those with vaccine hesitancy.

Listen now at or wherever you get your podcasts, including Apple, Google, and Spotify.


Biotech innovation is critical to strengthening the economy and addressing climate change

Pandemic, climate change, economic crisis. How can we address these challenges? With the bioeconomy—and specifically, improving access to biotech innovation. Here’s our advice to the U.S. Department of Agriculture (USDA).

On Friday, BIO submitted comments in response to the USDA’s request for input on agricultural innovations

This is part of the USDA’s goal to reduce the environmental footprint of agriculture by half, while increasing production by 40 percent, according to the agency’s vision statement released in February.

BIO stressed the importance of bolstering the bioeconomy, through the development of new platform technologies, enhancements in agriculture and food production, and increased production of sustainable fuels, renewable chemicals, and biobased products.

We based our recommendations on five key principles:

  1. Advance Modern Regulatory Approaches to Keep Pace with Innovation
  2. Provide Robust Funding of Public and Private Sector Scientific Research
  3. Modernize Infrastructure
  4. Incentivize Farmers
  5. Build Public Support and Increase Market Access for Innovative Technologies

COVID-19 has only increased the importance of these goals, creating renewed urgency to protect public health and improve the wellbeing of people, animals, and the environment as the pandemic has highlighted the links between all three.

Dana’s Dialogue: The vulnerabilities in our supply chains exposed by the COVID-19 pandemic—which will only be compounded by climate change—emphasize the need to create a more resilient world through science. We have an obligation to learn from this crisis and apply those learnings to build a better tomorrow. That means taking steps to invest in science, innovation, and the workforce needed to create resilient industries and maintain global economic strength. – Dana O’Brien, EVP of BIO’s Food and Agriculture Section 

Learn more about how the bioeconomy is solving some of the world’s biggest challenges.

BIO Beltway Report

President Trump’s Monday: Meeting with U.S. tech workers and signing an executive order on “hiring American.” 

What’s Happening on Capitol Hill: Recess is delayed in hopes of making progress on the next coronavirus aid package, reports POLITICO.

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